Associate Director, Regulatory Affairs, CMC

SUMMARY:

Aspen is looking for a detail-oriented professional eager to grow their career as Associate Director of Regulatory Affairs, CMC. This role will help lead the establishment and execution of regulatory strategies and submissions process. Key responsibilities for this position include developing regulatory CMC strategies to support the clinical development of the company’s investigational product(s), leading the preparation of CMC sections of regulatory submissions, interacting with global regulatory authorities, and providing relevant guidance to cross-functional teams to ensure that all applicable regulatory requirements are appropriately met.

DUTIES AND RESPONSIBILITIES:

• Proactively managing CMC aspects of one or more development programs including overseeing preparation and submission of CMC submissions, including clinical trial applications.
• Ensure that CMC content is complete, well-written, and meets all relevant requirements.
• Stay abreast of current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and provide regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups and stakeholders.
• Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects.
• Participates in the design, development and implementation of department strategies, regulatory risk management and contingency plans, providing recommendations in area of expertise.
• Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development.
• Managing interactions with FDA and other global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of clinical trial applications and other submissions which present CMC information.
• May perform other duties as assigned.

EDUCATION AND EXPERIENCE:

• Bachelor's Degree required (life sciences disciplines strongly preferred).
• Minimum 6 years’ relevant experience in regulatory affairs or related functions in drug or biologics development.
• Cell and Gene therapy experience preferred.
• Experience as a regulatory contributor for global original IND, NDA, MAA filings in the US or Europe is preferred.

JOB SPECIFICATIONS:

• Excellent interpersonal skills to communicate difficult concepts and persuade others.
• Strategic thinking and strong problem-solving skills with outstanding attention to detail.
• Collaborates and communicates in an open, clear, complete, timely, and consistent manner.
• Strong sense of planning and prioritization, and the ability to work with all levels of management.
• Advanced knowledge in regulatory (FDA, EMA, Health Canada, and ICH) guidelines.
• Sound knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process.
• Effective decision-making skills; makes good business decisions and exercises sound judgment.
• Consistently and effectively balances decisions with imperatives for ethics and efficacy.
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat.

EEO and Employment Eligibility

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees.

Total Rewards and Culture

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.